The US Food and Drug Administration has given its marketing nod for efgartigimod, branded as Vyvgart, a first-in-class, targeted therapy for adults with generalized myasthenia gravis (gMG) who test positive for the antiacetylcholine receptor (AChR) antibody. The FDA approval for the drug is an important step as there are significant unmet medical needs for people living with myasthenia gravis, a rare and chronic autoimmune neuromuscular disorder. Vyvgart provides a novel therapy option for patients for people living with rare disease, which causes debilitating and potentially life-threatening muscle weakness and significantly impaired independence and quality of life.